KR20140006236A - Therapy device for tinnitus and hardness of hearing - Google Patents

Abstract

The present invention relates to an earpiece for LLLT with a simple structure, capable of effectively curing tinnitus and hardness of hearing and an appended device. More specifically, provided is a therapy device for tinnitus and hardness of hearing, which directly emits low level laser light of a singular wavelength or multiple wavelengths to the inner ear part via the external auditory canal and emits laser light of a relatively long wavelength to an auditory nerve system by transcutaneous application.

Description

Tinnitus and Hearing Loss Treatment Device {THERAPY DEVICE FOR TINNITUS AND HARDNESS OF HEARING}

Tinnitus refers to a symptom that is perceived as a continuous or intermittent noise heard in the ear, even if there is no external sound source, the patient is suffering from a headache, sleep disorders, nervous breakdowns, depression, etc. caused by the above sounds and severely impaired in everyday life.

Tinnitus has increased rapidly in recent years with changes in the social environment. According to one statistics, 15-20% of adults suffer from tinnitus, and 4-5% are severely in need of treatment. It is known. Tinnitus increases with older people, according to one statistics, more than 80% of people over 40 years old. Therefore, considering the aging trend of modern society, the development of effective treatment for tinnitus is a very important task.

The causes of tinnitus and hearing loss are extremely diverse and there are many individual differences, and it is known that there are many abnormalities in the tympanum, inner ear tissues, and auditory nerve system. Among them, sensation (aging) of the sensory nervous system is most common, and in addition to the above, long-term exposure to excessive noise environment may be a direct cause. In either case, the theory that cochlea hair cells may be heard in the form of tinnitus is a kind of neuro-electrical signal spurious that occurs as a result of damage or degeneration by disease, aging, overwork, and the like. However, there are other physical diseases that can be the cause, especially circulatory disorders, mental anxiety and stress.

Therefore, there are various treatments for tinnitus. Until now, pharmacological treatments such as sedatives, anticonvulsants, antidepressants, local anesthetics, antihistamines, antipsychotics, and muscle relaxants have been mainly applied. . Recently, antioxidant therapy, transcutaneous electrical stimulation (TES), repetitive transcranial magnetic stimulation (rTMS), sound therapy, and tinnitus retraining therapy Tinnitus retraining therapy (TRT) and cognitive behavioral therapy are combined with pharmacotherapy, which is often less effective or temporary.

Recently, low-level laser therapy (LLLT), which treats various diseases and activates biological functions by irradiating low-power laser light to the affected area and utilizing photochemical effects of light energy, has been used in various clinical fields. However, the present invention is intended to apply this to tinnitus treatment and hearing loss.

The LLLT is a low-level laser light in the range of 10 ~ hundreds of mW in the far-infrared to near-infrared region to irradiate the living tissue to use the unique photochemical effect of the light energy in the treatment of diseases It is known that even non-professional procedures have no side effects, are safe, and are superior to the conventional methods in terms of simplicity and economy.

When the light in the above range is irradiated to biological tissues, the light energy is absorbed by the intracellular membranes and cytochrome c oxidase (CCO) and porphyrin in mitochondria. Singlet oxygen is generated to create a potential gradient between the cell and mitochondrial membranes, which increases cell membrane permeability and improves Adenosine Triphosphate (ATP) levels. The results indicate that increased capillary production, increased DNA production, increased oxygen support in the blood, increased collagen production, increased activity of lymphoids, increased granulation, phagocytosis ( phagocytosis), and as a result, it has been found to have the effect of improving the immunity of cellular tissues, healing damaged tissues, preventing and rejuvenation by aging.

  Therefore, it has been confirmed in recent experiments that the therapy can be applied to inner ear tissues, including the cochlea, to prevent degeneration of the cochlea, a major cause of tinnitus and hearing loss, and to lead to the regeneration of damaged auditory hair cells.

It is known that the biggest cause of tinnitus is the deterioration or degeneration of the auditory nerve system, and the hearing loss due to hair cell damage or degeneration of the cochlea is a major cause of tinnitus. Therefore, it has been tried to apply the LLLT to the auditory nervous system to solve the tinnitus or hearing loss problem.

Michael Seidman, MD, et al. Found that ALC (Acetyl-L-Carnitine) and ALA (Alpha Lipoic Acid) prevent the cochlea damage from aging, and that the effect is highly dependent on the mitochondrial metabolism. I knew that. Therefore, irradiating the laser light to the inner ear, it stimulated the mitochondria of this part, promoted the production of ATP, activated the entire auditory tissue including the cochlea and prevented the degeneration, and as a result, it was confirmed that hearing loss and tinnitus could be cured.

At one point, Luts Wilden, MD, of the Bad Fussing LLLT Research Center in Germany, irradiated laser light of 635-830 nm to the inner ear tissue and found that the damaged cells of the cochlea were healed. It has been shown that LLLT can solve the problem of hearing loss and tinnitus.

However, for this method, it is necessary to irradiate the laser light to the inner ear tissue including the cochlea in a safe and effective way, which requires not only high level of expertise in the procedure but also difficult adjustment of the optimal wavelength and power for general non-experts. It is known to be difficult to spread.

Cochlear and auditory nerve tissues that are closely related to hearing and tinnitus are located deep inside the inner ear tissue in the head, so it is not easy to irradiate laser light effectively. Therefore, it is necessary to develop a device that can be easily and safely mounted and used by non-experts.

In general, light beams suitable for LLLT are known to have wavelengths in the near-infrared range from far-red light. The light rays in the above range pass well through the water or blood in the tissue, and 35% or more of them are absorbed by the CCO of the mitochondria, contributing to the production of ATP. Several experiments to date have reported that light having the wavelengths of 610 to 625 nm, 660 to 690 nm, 750 to 770 nm, and 815 to 860 nm has the largest photo-biological effect.

In addition, the amount of irradiation energy is the best effect when applied once or twice per day 4 ~ 6J per 1cm ^ 2 biological tissue area, it is also found that the dose above the level is rather negatively working. However, the above case refers to the energy directly irradiated to the tissue of the treatment site, and in the case of trans cutaneous application, it is necessary to consider the amount of attenuation due to the epidermis, the fat layer, the skeleton, etc. present in the path from the skin to the affected area. Because you can not determine uniformly.

 Until now, clinical reports have generally applied a method of applying light power in the range of 50 to 500 mW / cm ^ 2 to the skin surface near the treatment area continuously or intermittently for several weeks to several months.

However, in the LLLT of the inner ear tissue including the cochlea, the laser light irradiator can be introduced through the ear canal, so there is an advantage that direct irradiation of the affected area is possible, rather than a transdermal irradiation such as LLLT of general body tissue. To this end, it is necessary to develop an earpiece having a structure that can safely insert the laser light irradiation unit to the nearest distance of the cochlea through the ear canal.

In addition, when the earpiece is inserted into the ear canal, the sound path is completely blocked, so external sound cannot be heard during treatment. Therefore, it is desirable to have a structure that can hear external sound while wearing the earpiece.

In general, a patient with severe tinnitus is often accompanied by a hearing loss disorder, so that the hearing aid function may be added to the LLLT earpiece to enable long-term treatment without disturbing daily life.

Tinnitus and hearing loss are often caused by the degeneration or abnormality of not only the cochlea but also the surrounding large tissues. Therefore, if the LLLT is applied to the entire temporal region to activate the function of a wider range of blood vessels and nerves near the cochlea, the tinnitus treatment may be more effective. Therefore, a method for transcutaneous application may be considered by mounting another laser light irradiation unit under the earlobe outside the ear canal. In this case, laser light having a relatively long wavelength having high transmittance is used, and a device for the above needs to be developed.

The present invention inserts an earpiece having a small laser diode (LD) attached to the ear canal to directly irradiate laser light to the cochlea and its surrounding tissues, and also to the temporal sublingual region under the earlobe. A single LD is mounted to transcateously radiate laser light throughout the auditory organ to activate or rejuvenate the entire auditory nervous system. Since the temporal region and the part do not have a skull, it is easy to apply the transdermal irradiation method of laser light.

For this purpose, the LLLT tinnitus and deafness treatment device of the present invention is an earpiece made so that one or two LDs having a wavelength in the range of 600 to 860 nm can be inserted into the ear canal, and separately from the temporal and sublingual lobe (側頭). It consists of a headset or ear set with an LD unit consisting of one LD in the range of 800 to 1000 nm to be mounted on the lower part, and a power controller for driving and controlling them.

1 is a model showing the appearance of the laser beam irradiated throughout the inner ear portion including the cochlea in the tinnitus and hearing loss treatment device of the present invention.

The ear canal earpiece is a method of mounting a small LD on the end of a lipophilic plastic or silicone tube that can be inserted into the ear canal, and the LD is embedded in the controller to guide the light output to the end of the earpiece through an optical fiber. And a method of directly irradiating through the diffusion lens at the optical fiber tip.

The ear canal earpiece is blocked by the earpiece during use so that external sounds cannot be heard, so the earpiece is characterized in that an acoustic hole is made to allow external sound to enter during use.

In general, Lee Myung patients often have hearing loss. Therefore, the ear canal insertion earpiece is characterized in that a small hearing aid can be added.

In the present invention, in order to maximize the therapeutic effect, the LD unit for percutaneous dermal LLLT is installed in the sublingual temporal and sublingual region, and for this, LD of a relatively long wavelength range of 800 to 1000 nm is used. do.

The course of tinnitus treatment by LLLT is relatively mild and requires a long period of time, ranging from weeks to months. Therefore, for patients with severe tinnitus, a combination of masking therapy can reduce the tinnitus from the beginning of the treatment, so the psychotherapeutic effect can be expected.

It is well known for the masking effect of sound that a tinnitus patient hears an appropriate synthesized sound so that the tinnitus is shielded and the tinnitus is not felt, and tinnitus masking therapy using this phenomenon is also known. The tinnitus blocking effect by this method works only while the masking sound is being applied, and the tinnitus recurs when the masking sound source is removed. However, some patients reported that tinnitus was not heard for a considerable time even after the masking sound source was removed. In particular, when LLLT was used, tinnitus shielding time after masking sound source was removed was reported to be longer.

In the present invention, by using a masking sound source in the earpiece by using the masking therapy in combination with the LLLT to allow the patient to recognize that the tinnitus is removed from the beginning of the treatment is characterized in that also combines the effects of psychotherapy. The frequency, waveform, intensity, etc. of the masking sound source are optimally defined according to the patient. In this case, the masking sound source controller is externally controlled so as to be optimally controlled.

The earpiece LD and the external LD are driven as independent power controllers, which are programmed to automatically input the irradiation output, the irradiation time, and the operation sequence of the LD in advance.

All of the above components are characterized in that they are assembled in a headset or earset type for easy use by non-experts.

In the present invention, the LD is inserted into the ear canal to directly irradiate the laser light to the cochlea and its surrounding tissues, or another LD is also mounted to the temporal sublingual region under the earlobe and transcutous to the entire inner ear. By using each of the above methods by evenly irradiating light, it is possible to effectively activate or rejuvenate the auditory nervous system.

Finally, the present invention provides a safe and effective means for enhancing the effect of treating tinnitus or hearing loss by promoting activation or regeneration of auditory nervous system.

Figure 1 is a model diagram illustrating the irradiation range of the LLLL when a tinnitus and hearing loss laser light therapy device of the present invention
2 is a cross-sectional view of a single LD irradiated earpiece for inserting the ear canal of the present invention.
Figure 3 is a cross-sectional view when hearing aids are added to the single LD irradiated earpiece for inserting the ear canal of the present invention.
Figure 4 is a structural diagram having an earpiece and an external unit of the tinnitus and hearing loss laser light treatment device of the present invention
5 is a view showing an example of mounting the tinnitus and hearing loss laser light treatment device of the present invention
Figure 6 is a view having a controller for tinnitus and hearing loss laser light treatment device of the present invention
Fig. 7 is a view showing an earpiece cross section and a controller when a plurality of LD-optical fiber illumination sets are used in a plurality of LD irradiation type earpieces for inserting the ear canal of the present invention.
8 is a cross-sectional view of an earpiece and a controller when a single LD-optical fiber illumination type is used by combining a plurality of laser lights using an optical multifunction apparatus in the multiple LD irradiation type earpiece for inserting the ear canal of FIG.
9 is a cross-sectional view of the earpiece and the controller when the masking sound generator is used in the ear canal insert type LD irradiation earpiece of FIGS. 7 to 8.
10 is a diagram showing the overall tinnitus treatment progress when applying Example 3 of the present invention.

The treatment device of the present invention is directly inserted into the ear canal as shown in FIG. 1, and the external ear canal insertion unit 10, 20, 30 for irradiating laser light directly to the cochlea and its surrounding tissues and the temporal sublingual region under the earlobe. It is composed of an external unit 40 to be installed and percutaneously irradiated laser light throughout the inner ear.

The following examples will be cited.

Example 1.

2 to 6 show a tinnitus and hearing loss treatment apparatus according to the first embodiment.

The earpiece is made of a plastic skin or silicone tube 101 made to be inserted into the ear canal lightly, as shown in Fig. 2, and the laser diode LD 11 is mounted at one end thereof and the power line 172 is connected to the controller. The connection is established.

LD (11) is selected from the wavelength range of 610nm ~ 780nm is known to use the most effective wavelength through clinical experiments. Preferably, an LD of 660 nm wavelength type and 780 nm wavelength type may be selected, and its light output may be in the range of 50 to 300 mW / cm ^ 2.

The earpiece drills an acoustic hole 16 so that external sound may enter even when inserted into the ear canal.

Since the outer unit 40 is an irradiator for transdermal LLLT, LD having a long wavelength with attenuation due to skin and fat layers is used. However, in the infrared region, the thermal effect is larger than the biological effect, so that it generally does not exceed the wavelength range of 800 to 1000 nm. Preferably, the 808 nm wavelength type is adopted and the light output is in the range of 50 to 800 mW / cm ^ 2. do.

The ear canal insert earpiece 10 and the outer unit 40 are fixed to the ear hook 50 made of a flexible material as shown in FIG. 4 so that the patient's treatment can be easily attached to the ear of the desired side as shown in FIG. If both ears require treatment, symmetrical connections are used as shown in FIG.

At the time of treatment, the controller 70 controls the waveform, the length, and the time interval of the driving power applied to the angle by a predetermined program.

For patients with a lot of hearing loss, the earpiece 20 is made of a structure incorporating a hearing aid as shown in FIG. 3. In the above, the external sound is input to the amplifier 151 through the sound absorbing hole 14, amplified, output from the speaker 15, and transmitted to the ear canal through the output hole 16.

Example 2.

As described above, the irradiation light for LLLT differs in the optimum wavelength depending on the location, site, and the like of the irradiated biological tissue. Therefore, it has been reported that irradiating a plurality of different wavelengths of light at the same time than a single wavelength can obtain a better therapeutic effect. However, since it is difficult to fix a plurality of LDs at the narrow earpiece ends, it is conceivable to place the LD unit externally and induce its light output to the ear canal as an optical fiber to emit from the earpiece end.

7 illustrates the use of two different wavelengths of laser light, where the LDs 113 and 114 are embedded in an external controller unit 200, and the light outputs are respectively represented by the independent optical fiber 115 and the earpiece 103. After inducing to the end, the two optical fiber terminals (111, 112) are to emit each. The power of the controller unit 200 may be supplied by the controller unit power line 173 or the battery 116 may be built in the controller unit 200 to be portable.

Here, the two LDs are selected so that the stackers of the output light do not overlap with each other in the range of 610 nm to 780 nm, but preferably among the wavelengths disclosed for effectiveness in clinical cases so far. In addition, the light output is made to be generally in the range of 10 ~ 500mW / cm ^ 2 at the terminal of the fiber.

 The controller 116 is configured to independently control the waveform, the length, and the time interval of the driving power applied to each of the LDs 113 and 114 by a predetermined program.

Example 3.

8 illustrates the use of three different wavelengths of laser light, where each LD 114 is compounded using the optical multifunction device 117 without using a unique optical fiber, and then the earpiece as a single optical fiber 115. 103) After inducing to the end, it is emitted from a single optical fiber terminal 112.

In this case, the three LDs are selected so that the stackers of the output light do not overlap each other in the range of 610 nm to 780 nm. Preferably, the LDs are selected from the wavelengths that have been disclosed in the clinical cases so far. It should be in the range of 10 ~ 500mW / cm ^ 2.

The controller 116 is configured to independently control the waveform, length, and time interval of the driving power applied to each LD 114n by a predetermined program.

Example 4.

In the fourth embodiment, a masking treatment is added to the second embodiment, and a masking sound source is built into the earpiece as shown in FIG. 9 so that masking sound is applied to the ear canal during LLLT treatment to suppress tinnitus on the fly. . The effects of LLLT begin to appear after several months, but when combined with masking therapy, the tinnitus is felt at the beginning of treatment, and as the LLLT treatment progresses, the ringing effect persists even after the masking sound is removed. Because of this, more effective tinnitus treatment is possible.

The masking treatment sound generates an acoustic signal of preset frequency, intensity, and waveform in the masking sound generator 300, and the signal is supplied to the small speaker 301 in the earpiece 103 via the signal line 302. do. The output of the small speaker 301 is emitted to the ear canal through the sound hole 16 at the end of the earpiece, and this sound acts on the auditory nerve system, which is the source of tinnitus, to treat tinnitus as a masking effect. At the same time, since laser light emitted from the optical fiber terminals 111 and 112 is irradiated near the cochlea, LLLT treatment is also performed.

Figure 10 shows the overall tinnitus treatment progress when the Example 4 is applied. That is, at the beginning of treatment, tinnitus is reduced by the masking effect because the effect of LLLT is not heard well, and tinnitus is significantly reduced by LLLT as the treatment period elapses, and after a certain period, tinnitus is reduced even if there is no masking sound source. It can be removed.

In addition, the masking sound has an optimum sound such as frequency, waveform, intensity, etc. according to the characteristics of the tinnitus patient, which allows the external masking sound generator 300 to adjust it.

10, 20, 30: ear canal insertion unit 40: external unit
50: ear hook 60: power line
70: controller 171, 172: power line
16: acoustic ball 101, 102: silicon tube
11: LD 103: Earpiece
151 amplifier 14 blowing hole
15: speaker 16: sound ball
111, 112: optical fiber terminal 113, 114: LD
116 controller 115 optical fiber
200: controller portion 173: controller portion power line
117: optical multifunction device 300: masking sound generator
302: signal line 301: small speaker

Claims (11)

Directly irradiating short- or multi-wavelength low-power laser light into the inner ear via the ear canal; The laser beam externally fixed to the lower temporal region and irradiated relatively long wavelength laser light to the auditory nerve system percutaneously; Tinnitus and hearing loss treatment device characterized in that. The method of claim 1,
The ear canal irradiation light has a structure in which a single or a plurality of small LDs are mounted at the end of an earpiece suitable for insertion into the ear canal. The method of claim 1,
The ear canal is irradiated from the singular or plural laser beams provided in the external controller to the earpiece having a structure suitable for insertion into the ear canal through optical fibers, respectively, and then is directly emitted from the end of the optical fiber to the inner ear. Hearing loss treatment device. The method of claim 1,
The ear canal is irradiated from the singular or plural laser beams provided in the external controller by an optical multifunction device to be transmitted to the earpiece as a single optical fiber, and then directly emitted from the end of the optical fiber to the inner ear. Hearing loss treatment device. The method according to any one of claims 2 to 4,
The earpiece treatment device for hearing and hearing loss, characterized in that the earpiece is made of a sounding hole that can receive external sound even during treatment. The method according to any one of claims 2 to 4,
The earpiece is a tinnitus and hearing loss device characterized in that the sound hole is made so that the external sound can reach the eardrum even during the treatment. The method according to any one of claims 2 to 4,
Tinnitus and hearing loss treatment device characterized in that the hearing aid is attached to the earpiece for hearing loss patients. The method according to any one of claims 2 to 4,
Tinnitus and hearing loss treatment device, characterized in that by adding a masking sound source to the earpiece by using a masking therapy with the LLLT effect in the treatment of tinnitus or hearing loss.
According to claim 1 or 2
LD to be attached to the earpiece tip has a wavelength in the range of 610nm to 780nm and its output is in the range of 10 ~ 500mW / cm ^ 2.
The method of claim 1, wherein
LD to be attached to the lower part of the earlobe is in the range of 800 ~ 1000nm and its output is in the range of 50 ~ 800mW / cm ^ 2.
The method according to claim 3 and 4
A plurality of LDs to be used in combination should have wavelengths within the range of 610nm to 780nm, but preferably so that each specter does not overlap each other, and the radiant power of the optical fiber tip is in the range of 10 ~ 500mW / cm ^ 2.

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